Atrial Fibrillation, Persistent Atrial Fibrillation
Conditions
Keywords
ablation, electrophysiology, atrial fibrillation, catheter, persistent
Brief summary
The purpose of the Diamond-AF II study is to establish the safety and effectiveness of the DiamondTemp Ablation System for the treatment of drug refractory, symptomatic persistent atrial fibrillation in patients.
Detailed description
The DIAMOND-AF II Study is a prospective, non-randomized (single-group assignment) trial being performed at multiple centers in the United States, Canada and Europe to evaluate the safety and effectiveness of the DiamondTemp Ablation System for the treatment of patients with persistent atrial fibrillation.
Interventions
DEVICERadiofrequency Ablation
A procedure will be performed using a radiofrequency ablation catheter.
Sponsors
Medtronic Cardiac Ablation Solutions
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Above eighteen (18) years of age or of legal age to give informed consent specific to state and national law. 2. Subjects with a history of documented symptomatic, persistent Atrial Fibrillation with 1) a physician's note documenting a continuous AF episode lasting longer than 7 days but less than 12 months AND 2) two electrocardiograms from any form of rhythm monitoring showing continuous AF taken at least 7 days apart OR a 24-hour Holter within 180 days of the ablation procedure showing continuous AF. 3. Refractory, intolerant or contraindicated to at least one Class I or III anti-arrhythmic (AAD) drug. 4. Suitable candidate for intra-cardiac mapping and ablation of arrhythmia. 5. Subject agrees to comply with study procedures and be available (geographically stable) for follow-up visits for at least 12 months after enrollment. 6. Subject is willing and able to provide written consent.
Exclusion criteria
At time of enrollment and/or prior to procedure: 1. Continuous AF \>12 months (long-standing persistent AF) 2. Paroxysmal AF with longest episode \<7 days 3. AF secondary to electrolyte imbalance, thyroid disease or reversible or non-cardiac cause 4. Rheumatic heart disease 5. Severe mitral regurgitation 6. Hypertrophic cardiomyopathy 7. LA diameter \>5.5 cm 8. Left ventricular ejection fraction (LVEF) \<40% 9. Currently NYHA Class III or IV or exhibits uncontrolled heart failure 10. Body Mass Index (BMI) \>42 kg/m2. 11. LA ablation, septal closure device or mitral valve surgical procedure at any time prior to enrollment 12. Presence of intramural thrombus, tumor or abnormality that precludes vascular access, catheter introduction or manipulation 13. Coagulopathy, bleeding diathesis or suspected procoagulant state 14. Sepsis, active systemic infection or fever (\>100.5 oF / 38 oC) within a week prior to the ablation procedure 15. Significant restrictive or obstructive pulmonary disease or chronic respiratory condition 16. Renal failure requiring dialysis or renal compromise that in the investigator's judgement would increase risk to the subject or deem the subject inappropriate to participate in the study. 17. Known allergies or intolerance to anticoagulant and antiplatelet therapies to be used in conjunction with the study or contrast sensitivity that cannot be adequately pre-treated prior to the ablation procedure. 18. Positive pregnancy test results for female subjects of childbearing potential or breast feeding. 19. Enrollment in a concurrent clinical study that in the judgement of the investigator would impact study outcomes. 20. Acute or chronic medical condition that in the judgment of the investigator would increase risk to the subject or deem the subject inappropriate to participate in the study. 21. Life expectancy \<12 months based on medical history or the medical judgement of the investigator. Within 1 month of enrollment or just prior to procedure: 22. Documented LA thrombus upon imaging 23. Creatinine \>2.5mg/dl or creatinine clearance \<30mL/min Within 3 months of enrollment: 24. Significant gastrointestinal (GI) bleed 25. Myocardial infarction (MI), unstable angina, cardiac surgery or coronary intervention Within 6 months of enrollment: 26. Coronary artery bypass graft (CABG) procedure 27. Implant procedure performed for ICD, CRT leads or pacemaker 28. Documented stroke, CVA, TIA or suspected neurological event
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety Events | Ablation through 6 months | Participant count of a composite of safety events including: serious adverse events (SAEs), procedure and/or device-related significant pericardial effusion, severe or clinically symptomatic pulmonary vein stenosis and atrioesophageal fistula |
| Primary Effectiveness | 12 months | The primary effectiveness endpoint is defined as freedom from documented AF, Atrial Flutter, (AFL) and Atrial Tachycardia (AT) episodes following the blanking period (3-month follow-up post-ablation procedure) through the end of the effectiveness evaluation period (12-month follow-up post-ablation procedure). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Single Procedure Success With Freedom From AF/AT/AFL | 12 months after the index ablation procedure | Participant count of single procedure success defined as the rate of subjects treated with one single ablation procedure for the entire enrollment period and with freedom from documented symptomatic AF, AT and AFL\* at 12 months. |
| AFEQT Quality of Life, Baseline | Day of index ablation procedure | QOL using the AFEQT Questionnaire, baseline questionnaires. The scale is the AF Effect on Quality-of-Life (AFEQT) score. Higher scores are better. Minimum value: 0. Maximum value: 100. |
| AFEQT Quality of Life, 6-month Follow-up | 6 months after index ablation procedure | QOL using the AFEQT Questionnaire, 6 month questionnaires. The scale is the AF Effect on Quality-of-Life (AFEQT) score. Higher scores are better. Minimum value: 0. Maximum value: 100. |
| AFEQT Quality of Life, 12-month Follow up | 12 months after index ablation procedure | QOL using the AFEQT Questionnaire, 12-month questionnaires. The scale is the AF Effect on Quality-of-Life (AFEQT) score. Higher scores are better. Minimum value: 0. Maximum value: 100. |
| Change in AFEQT Quality of Life From Baseline to 12-month | Index ablation procedure through 12 months | Changes in QOL using the AFEQT Questionnaire between 12-month and baseline questionnaires. The scale is the AF Effect on Quality-of-Life (AFEQT) score. Higher scores are better. Minimum value: 0. Maximum value: 100. |
| National Institutes of Health Stroke Scale, Pre-discharge | Day of index ablation procedure | Neurological changes measured using the National Institutes of Health Stroke Scale (NIHSS) The NIHSS which is comprised of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score possible is 0. |
| National Institutes of Health Stroke Scale, One- Month Follow up | One month after index ablation procedure | Neurological changes measured using the National Institutes of Health Stroke Scale (NIHSS) The NIHSS which is comprised of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score possible is 0. |
| National Institutes of Health Stroke Scale, 12-month Follow-up | 12 months after the index ablation procedure | Neurological changes measured using the National Institutes of Health Stroke Scale (NIHSS) The NIHSS which is comprised of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score possible is 0. |
| Freedom From a Composite of Serious Adverse Events (SAEs) | Within 30-days post-index ablation | Freedom from a composite of SAEs occurring within 30-days post-index ablation procedure as adjudicated by an independent CEC for relatedness to the procedure or device. |
| Freedom From Documented AF/AFL/AT Episodes | Within 3 months | Freedom from documented AF/AFL/AT episodes during the effectiveness evaluation period lasting ≥ 30 seconds in duration by ECG monitoring. |
| Freedom From Documented AF/AFL/AT Episodes in the Absence of Class I and III Anti-arrhythmic Drug Therapy. | Within 3 months | Freedom from documented AF/AFL/AT episodes during the effectiveness evaluation period in the absence of class I and III anti-arrhythmic drug therapy. |
| Acute Procedural Success | Day of index ablation procedure | Participant count of acute procedural success, defined as confirmation of electrical isolation of PVs via assessment of entrance block at least 20 minutes following the last ablation around the respective PV |
| Single Procedure Success With Freedom From All Primary Effectiveness Failures | 12 months | Participant count of single procedure success with freedom from all primary effectiveness failure criteria. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Duration of RF Ablations (Seconds) | Day of index ablation procedure | Mean duration of RF ablations (seconds) |
| Fluid Infused Through the Investigational Catheter (mL) | Day of index ablation procedure | Total fluid infused through the investigational catheter (mL) |
| Fluoroscopy Time (Minutes) | Day of index ablation procedure | Total fluoroscopy exposure time (minutes) |
| Incidence of Re-hospitalizations Due to Atrial Fibrillation Recurrence. | Between the blanking period (3-month follow-up post-ablation procedure) through the end of the effectiveness evaluation period (12-month follow-up post-ablation procedure). | Number of subjects who were re-hospitalized due to atrial fibrillation recurrence after blanking period. |
| Total Treatment Device Time (Minutes) | Day of index ablation procedure | Total treatment device time (minutes), defined as time of delivery of first RF ablation with investigational catheter to removal of the investigational catheter. |
| Total Procedure Time (Minutes) | Immediately after the index ablation procedure | Total procedure time (minutes), defined as time of investigational catheter insertion into the vasculature to time of last procedural ablation catheter removed. |
| Cumulative RF Time | Day of index ablation procedure | Mean cumulative RF Time (minutes). |
Countries
Canada, Czechia, France, Germany, Italy, United States
Participant flow
Recruitment details
Recruitment for the study occurred from September 2018 to November 2023. The first subject was enrolled on September 19, 2018, and the last patient visit occurred on October 31, 2024.
Pre-assignment details
Of the 376 subjects enrolled, 15 exited the study prior to undergoing ablation and were not included in the intent-to-treat (ITT) population. These subjects may have exited for various reasons including withdrawal of consent or clinical exclusion criteria discovered after enrollment. Baseline assessments were conducted prior to ablation to confirm eligibility and ensure protocol compliance.
Participants by arm
| Arm | Count |
|---|---|
| Modified Intention-to-treat (mITT) Cohort All enrolled subjects underwent catheter ablation using the DiamondTemp™ Ablation (DTA) system. A total of 376 subjects were enrolled. Of these, 361 subjects underwent ablation and formed the intent-to-treat (ITT) population. Following ablation, subjects were followed for 12 months to assess safety and effectiveness outcomes. The mITT population (n=290) included subjects who met all eligibility criteria and were ablated.
Subjects not meeting all eligibility criteria (n=71) were still followed as part of a secondary analysis. The follow-up protocol included scheduled assessments and monitoring at predetermined time points up to 12 months post-ablation.
Exit reasons included voluntary withdrawal, death, or loss to follow-up. | 290 |
| Total | 290 |
Baseline characteristics
| Characteristic | Modified Intention-to-treat (mITT) Cohort |
|---|---|
| Age, Continuous | 66.0 years STANDARD_DEVIATION 8.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 231 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 45 Participants |
| Race/Ethnicity, Customized African | 4 participants |
| Race/Ethnicity, Customized Americas (Native North, South American, Canadian First) | 5 participants |
| Race/Ethnicity, Customized Caucasian (European descent) | 228 participants |
| Race/Ethnicity, Customized Other | 7 participants |
| Race/Ethnicity, Customized Unknown | 48 participants |
| Sex: Female, Male Female | 74 Participants |
| Sex: Female, Male Male | 216 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 361 |
| other Total, other adverse events | 22 / 361 |
| serious Total, serious adverse events | 78 / 361 |
Outcome results
Primary
Primary Effectiveness
The primary effectiveness endpoint is defined as freedom from documented AF, Atrial Flutter, (AFL) and Atrial Tachycardia (AT) episodes following the blanking period (3-month follow-up post-ablation procedure) through the end of the effectiveness evaluation period (12-month follow-up post-ablation procedure).
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Modified Intention-to-treat (mITT) Cohort | Primary Effectiveness | 198 participants |
Primary
Primary Safety Events
Participant count of a composite of safety events including: serious adverse events (SAEs), procedure and/or device-related significant pericardial effusion, severe or clinically symptomatic pulmonary vein stenosis and atrioesophageal fistula
Time frame: Ablation through 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Modified Intention-to-treat (mITT) Cohort | Primary Safety Events | 16 participants |
Secondary
Acute Procedural Success
Participant count of acute procedural success, defined as confirmation of electrical isolation of PVs via assessment of entrance block at least 20 minutes following the last ablation around the respective PV
Time frame: Day of index ablation procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Modified Intention-to-treat (mITT) Cohort | Acute Procedural Success | 289 participants |
Secondary
AFEQT Quality of Life, 12-month Follow up
QOL using the AFEQT Questionnaire, 12-month questionnaires. The scale is the AF Effect on Quality-of-Life (AFEQT) score. Higher scores are better. Minimum value: 0. Maximum value: 100.
Time frame: 12 months after index ablation procedure
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Modified Intention-to-treat (mITT) Cohort | AFEQT Quality of Life, 12-month Follow up | 88.0 score on a scale |
Secondary
AFEQT Quality of Life, 6-month Follow-up
QOL using the AFEQT Questionnaire, 6 month questionnaires. The scale is the AF Effect on Quality-of-Life (AFEQT) score. Higher scores are better. Minimum value: 0. Maximum value: 100.
Time frame: 6 months after index ablation procedure
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Modified Intention-to-treat (mITT) Cohort | AFEQT Quality of Life, 6-month Follow-up | 85.6 score on a scale |
Secondary
AFEQT Quality of Life, Baseline
QOL using the AFEQT Questionnaire, baseline questionnaires. The scale is the AF Effect on Quality-of-Life (AFEQT) score. Higher scores are better. Minimum value: 0. Maximum value: 100.
Time frame: Day of index ablation procedure
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Modified Intention-to-treat (mITT) Cohort | AFEQT Quality of Life, Baseline | 61.6 score on a scale |
Secondary
Change in AFEQT Quality of Life From Baseline to 12-month
Changes in QOL using the AFEQT Questionnaire between 12-month and baseline questionnaires. The scale is the AF Effect on Quality-of-Life (AFEQT) score. Higher scores are better. Minimum value: 0. Maximum value: 100.
Time frame: Index ablation procedure through 12 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Modified Intention-to-treat (mITT) Cohort | Change in AFEQT Quality of Life From Baseline to 12-month | 26.5 score on a scale |
Secondary
Freedom From a Composite of Serious Adverse Events (SAEs)
Freedom from a composite of SAEs occurring within 30-days post-index ablation procedure as adjudicated by an independent CEC for relatedness to the procedure or device.
Time frame: Within 30-days post-index ablation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Modified Intention-to-treat (mITT) Cohort | Freedom From a Composite of Serious Adverse Events (SAEs) | 273 participants |
Secondary
Freedom From Documented AF/AFL/AT Episodes
Freedom from documented AF/AFL/AT episodes during the effectiveness evaluation period lasting ≥ 30 seconds in duration by ECG monitoring.
Time frame: Within 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Modified Intention-to-treat (mITT) Cohort | Freedom From Documented AF/AFL/AT Episodes | 188 participants |
Secondary
Freedom From Documented AF/AFL/AT Episodes in the Absence of Class I and III Anti-arrhythmic Drug Therapy.
Freedom from documented AF/AFL/AT episodes during the effectiveness evaluation period in the absence of class I and III anti-arrhythmic drug therapy.
Time frame: Within 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Modified Intention-to-treat (mITT) Cohort | Freedom From Documented AF/AFL/AT Episodes in the Absence of Class I and III Anti-arrhythmic Drug Therapy. | 126 participants |
Secondary
National Institutes of Health Stroke Scale, 12-month Follow-up
Neurological changes measured using the National Institutes of Health Stroke Scale (NIHSS) The NIHSS which is comprised of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score possible is 0.
Time frame: 12 months after the index ablation procedure
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Modified Intention-to-treat (mITT) Cohort | National Institutes of Health Stroke Scale, 12-month Follow-up | Improved -3 from baseline to 12-month follow-up | 1 Participants |
| Modified Intention-to-treat (mITT) Cohort | National Institutes of Health Stroke Scale, 12-month Follow-up | Worsened +2 from baseline to 12-month follow-up | 1 Participants |
| Modified Intention-to-treat (mITT) Cohort | National Institutes of Health Stroke Scale, 12-month Follow-up | Stayed the same +0 from baseline to 12-month follow-up | 228 Participants |
| Modified Intention-to-treat (mITT) Cohort | National Institutes of Health Stroke Scale, 12-month Follow-up | Improved -2 from baseline to 12-month follow-up | 0 Participants |
| Modified Intention-to-treat (mITT) Cohort | National Institutes of Health Stroke Scale, 12-month Follow-up | Improved -1 from baseline to 12-month follow-up | 4 Participants |
| Modified Intention-to-treat (mITT) Cohort | National Institutes of Health Stroke Scale, 12-month Follow-up | Worsened +1 from baseline to 12-month follow-up | 3 Participants |
Secondary
National Institutes of Health Stroke Scale, One- Month Follow up
Neurological changes measured using the National Institutes of Health Stroke Scale (NIHSS) The NIHSS which is comprised of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score possible is 0.
Time frame: One month after index ablation procedure
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Modified Intention-to-treat (mITT) Cohort | National Institutes of Health Stroke Scale, One- Month Follow up | Improved -3 from baseline to 1-month follow-up | 0 Participants |
| Modified Intention-to-treat (mITT) Cohort | National Institutes of Health Stroke Scale, One- Month Follow up | Stayed the same +0 from baseline to 1-month follow-up | 197 Participants |
| Modified Intention-to-treat (mITT) Cohort | National Institutes of Health Stroke Scale, One- Month Follow up | Worsened +1 from baseline to 1-month follow-up | 0 Participants |
| Modified Intention-to-treat (mITT) Cohort | National Institutes of Health Stroke Scale, One- Month Follow up | Improved -1 from baseline to 1-month follow-up | 1 Participants |
| Modified Intention-to-treat (mITT) Cohort | National Institutes of Health Stroke Scale, One- Month Follow up | Worsened +2 from baseline to 1-month follow-up | 0 Participants |
| Modified Intention-to-treat (mITT) Cohort | National Institutes of Health Stroke Scale, One- Month Follow up | Improved -2 from baseline to 1-month follow-up | 0 Participants |
Secondary
National Institutes of Health Stroke Scale, Pre-discharge
Neurological changes measured using the National Institutes of Health Stroke Scale (NIHSS) The NIHSS which is comprised of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score possible is 0.
Time frame: Day of index ablation procedure
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Modified Intention-to-treat (mITT) Cohort | National Institutes of Health Stroke Scale, Pre-discharge | Improved -3 from baseline to pre-discharge | 0 Participants |
| Modified Intention-to-treat (mITT) Cohort | National Institutes of Health Stroke Scale, Pre-discharge | Stayed the same +0 from baseline to pre-discharge | 282 Participants |
| Modified Intention-to-treat (mITT) Cohort | National Institutes of Health Stroke Scale, Pre-discharge | Worsened +2 from baseline to pre-discharge | 1 Participants |
| Modified Intention-to-treat (mITT) Cohort | National Institutes of Health Stroke Scale, Pre-discharge | Worsened +1 from baseline to pre-discharge | 2 Participants |
| Modified Intention-to-treat (mITT) Cohort | National Institutes of Health Stroke Scale, Pre-discharge | Improved -2 from baseline to pre-discharge | 0 Participants |
| Modified Intention-to-treat (mITT) Cohort | National Institutes of Health Stroke Scale, Pre-discharge | Improved -1 from baseline to pre-discharge | 1 Participants |
Secondary
Single Procedure Success With Freedom From AF/AT/AFL
Participant count of single procedure success defined as the rate of subjects treated with one single ablation procedure for the entire enrollment period and with freedom from documented symptomatic AF, AT and AFL\* at 12 months.
Time frame: 12 months after the index ablation procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Modified Intention-to-treat (mITT) Cohort | Single Procedure Success With Freedom From AF/AT/AFL | 172 participants |
Secondary
Single Procedure Success With Freedom From All Primary Effectiveness Failures
Participant count of single procedure success with freedom from all primary effectiveness failure criteria.
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Modified Intention-to-treat (mITT) Cohort | Single Procedure Success With Freedom From All Primary Effectiveness Failures | 155 participants |
Other Pre-specified
Cumulative RF Time
Mean cumulative RF Time (minutes).
Time frame: Day of index ablation procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Modified Intention-to-treat (mITT) Cohort | Cumulative RF Time | 47.6 minutes | Standard Deviation 34.8 |
Other Pre-specified
Duration of RF Ablations (Seconds)
Mean duration of RF ablations (seconds)
Time frame: Day of index ablation procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Modified Intention-to-treat (mITT) Cohort | Duration of RF Ablations (Seconds) | 17.0 seconds | Standard Deviation 22.2 |
Other Pre-specified
Fluid Infused Through the Investigational Catheter (mL)
Total fluid infused through the investigational catheter (mL)
Time frame: Day of index ablation procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Modified Intention-to-treat (mITT) Cohort | Fluid Infused Through the Investigational Catheter (mL) | 265.5 mL | Standard Deviation 121.9 |
Other Pre-specified
Fluoroscopy Time (Minutes)
Total fluoroscopy exposure time (minutes)
Time frame: Day of index ablation procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Modified Intention-to-treat (mITT) Cohort | Fluoroscopy Time (Minutes) | 13.6 minutes | Standard Deviation 17.6 |
Other Pre-specified
Incidence of Re-hospitalizations Due to Atrial Fibrillation Recurrence.
Number of subjects who were re-hospitalized due to atrial fibrillation recurrence after blanking period.
Time frame: Between the blanking period (3-month follow-up post-ablation procedure) through the end of the effectiveness evaluation period (12-month follow-up post-ablation procedure).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Modified Intention-to-treat (mITT) Cohort | Incidence of Re-hospitalizations Due to Atrial Fibrillation Recurrence. | 0 Re-hospitalizations | 285 Participants |
| Modified Intention-to-treat (mITT) Cohort | Incidence of Re-hospitalizations Due to Atrial Fibrillation Recurrence. | 1 Re-hospitalization | 5 Participants |
Other Pre-specified
Total Procedure Time (Minutes)
Total procedure time (minutes), defined as time of investigational catheter insertion into the vasculature to time of last procedural ablation catheter removed.
Time frame: Immediately after the index ablation procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Modified Intention-to-treat (mITT) Cohort | Total Procedure Time (Minutes) | 104.0 minutes | Standard Deviation 34.8 |
Other Pre-specified
Total Treatment Device Time (Minutes)
Total treatment device time (minutes), defined as time of delivery of first RF ablation with investigational catheter to removal of the investigational catheter.
Time frame: Day of index ablation procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Modified Intention-to-treat (mITT) Cohort | Total Treatment Device Time (Minutes) | 85.8 minutes | Standard Deviation 31.8 |